Family Navigator Intervention

NCT05954585 | Terminated DMC

• 1 other identifier: RIH.100
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and examine the feasibility and acceptability of a family navigator protocol while leveraging digital health communication. It will employ an ecological model within a socio-cultural theoretic framework of mental health service disparities and barriers to treatment.

Conditions

Treatment as Usual; Family Navigator

Keywords

emergency department, suicide, youth, family navigator

Outcome Measures

Primary Outcomes (1)

• Mental Health Services

  adapted CASA

  6 months

Secondary Outcomes (2)

• Suicidal ideation

  6 months

• Suicidal behavior

  6 months

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Emergency department treatment as usual

Behavioral: Treatment as usual

Family Navigator

EXPERIMENTAL

Follow provision provided by a Family Navigator for the length of the treatment or until youth attends community-based mental health care

Behavioral: Family Navigator

Interventions

Treatment as usual BEHAVIORAL

Emergency department treatment as usual

Treatment as usual

Family Navigator BEHAVIORAL

Family Navigator will speak with families about individual and systemic issues for linkage to mental health care biweekly for 3 months or until the youth's first mental health appt has been attended, whichever comes first.

Family Navigator

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• youth 10 to 14 years old living at home with legal guardian/caregiver

You may not qualify if:

• presentation including psychosis, sexual assault, or child abuse,
• are in police or child protective services' custody,
• are unable to assent due to severity of illness or developmental disabilities, \>cannot communicate in English or Spanish, or
• if no caregiver or legal guardian is able to provide consent.

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Emergencies; Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Mary Kathryn Cancilliere, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person conducting follow-up assessments will be masked as to the intervention assignments.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist / Assistant Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: December 2, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

US (1)